Local delivery of heparin post-PTCA: a multicenter randomized pilot study

Catheter Cardiovasc Interv. 2000 Apr;49(4):461-7. doi: 10.1002/(sici)1522-726x(200004)49:4<461::aid-ccd26>3.0.co;2-7.

Abstract

Bailout stenting for major dissection and threatened closure has high rates of ischemic complications. We performed a randomized trial of local heparin delivery using the infusion sleeve before bailout stenting for suboptimal angioplasty results. In phase I, 20 patients were randomized to local delivery with either 40- or 100-psi infusion pressure. In phase II, 37 patients were randomized to local delivery at 100 psi or standard therapy. Local delivery succeeded in all but one patient; overall there was no significant worsening of intimal dissection. One patient treated with 100-psi drug infusion suffered a perforation after stent placement. There were no significant differences in the composite endpoint of death, MI, CABG, urgent repeat angioplasty, and stent thrombosis at 30 days (21% vs. 0%; P = 0.18). At 6 months, the rates of myocardial infarction in phase II were 27% with local delivery vs. 10% with standard treatment (P = 0.4). Local heparin delivery in dissected vessels may be associated with increased complications and should be approached with caution.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Coronary Angiography
  • Coronary Thrombosis / diagnostic imaging
  • Coronary Thrombosis / drug therapy*
  • Coronary Vessels / drug effects*
  • Equipment Design
  • Feasibility Studies
  • Female
  • Heparin / administration & dosage*
  • Heparin / adverse effects
  • Humans
  • Infusions, Intra-Arterial / instrumentation
  • Male
  • Middle Aged
  • Pilot Projects
  • Risk Factors
  • Stents*

Substances

  • Heparin